CLASS II Device recall · Reported 1 Jul 2020 · FDA Enforcement Report
Atellica CH Chemistry Calibrator recalled
Siemens Healthcare Diagnostics is recalling Atellica CH Chemistry Calibrator, distributed nationwide in the US. The recall was initiated on 5 Jun 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2431-2020
- FDA event ID
- 85844
- Recalling firm
- Siemens Healthcare Diagnostics, Tarrytown, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2020
- FDA classified
- 26 Jun 2020
- Reported
- 1 Jul 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Device type
- Other Medical Devices
Timeline
| 5 Jun 2020 | Recall initiated by company | |
| 26 Jun 2020 | Classified by FDA | +21 days |
| 1 Jul 2020 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Atellica CH Chemistry Calibrator
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it recalled?
Calibration errors have been observed with the Total and Direct Bilirubin assays when using Chemistry Calibrator lot 534177 for ADVIA Chemistry and lot 534179 for Atellica CH.
Which lots are affected?
534179 (including sublots A, B, C, D and E) 911591 (including sublots A, B, and C) UDI: (01)00630414597492(10)534179(17)20211031 (01)00630414597492(10)534179A(17)20211231 (01)00630414597492(10)534179B(17)20211231 (01)00630414597492(10)534179C(17)20220131 (01)00630414597492(10)534179D(17)20220131 (01)00630414597492(10)534179E(17)20220331 (01)00630414597492(10)911591(17)20220331 (01)00630414597492(10)911591A(17)20220531 (01)00630414597492(10)911591B(17)20220531 (01)00630414597492(10)911591C(17)20220531
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85844This product is part of a recall event; the main page for the event is Advia Chemistry Calibrator recalled by Siemens Healthcare Diagnostics.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Advia Chemistry Calibrator recalled by Siemens Healthcare Diagnostics | Siemens Healthcare Diagnostics | Potency & Assay | Nationwide |
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